Phase 1, PK, Food Effect Study of PSN821

• Research type

  Research Study

• Full title

  An Open, Phase I, Randomised, Three Way Cross Over, Food Effect and Bioavailability Study of Novel Formulations of PSN821 (Compared to Suspension) in Healthy Male Subjects.

• IRAS ID

  57289

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Prosidion Ltd

• Eudract number

  2010-020811-35

• ISRCTN Number

  1

• Research summary

  The drug that is being tested is PSN821. PSN821 is being developed to treat Type 2 Diabetes. Type 2 diabetes results in dangerously high blood glucose levels and is often associated with being overweight. Current treatments for Type 2 Diabetes are only partially effective, have undesirable side effects and/or have to be given by injection. As a result, there is a need to develop an oral treatment that will be more effective but with fewer side effects. PSN821 is being developed for this purpose. Previous clinical studies carried out with PSN821 have shown it to be safe and well tolerated at doses up to 3000mg. The purpose of this study is to look at how much PSN821 gets into the blood stream when taken as a liquid (suspension) and as capsules. We will also be looking to see if the amount of PSN821 taken into the blood is affected by food. We will do this by taking blood samples to measure the levels of PSN821 in the blood when subjects have received PSN821 before eating (fasted) and 5 minutes after subjects have finished a high fat, fried breakfast (fed). If we need to we may also ask subjects to come back to look at the levels of PSN821 in the blood 5 minutes after they have finished a light breakfast of toast and jam. This will allow us to know whether it is better to give PSN821 before or after food and whether we can give as a liquid or capsule.

• REC name

  Wales REC 2

• REC reference

  10/WSE02/40

• Date of REC Opinion

  16 Jul 2010

• REC opinion

  Favourable Opinion